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OpenTrials
Completed

NCT Number: NCT00059722

This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
  • Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion criteria

  • Subjects who have received second-line or subsequent chemotherapy
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

Treatment and study plan

ZD6474

Drug

Placebo

Drug

ZD1839

Drug

Primary outcomes

  1. Primary Outcomes:

  2. Part A

  3. i. Time to progression

  4. ii. Incidence, CTC grade and type of Aes, clinically significant laboratory abnormalities or changes in vital signs, and ECG changes

  5. Part B

Secondary outcomes

  1. Secondary Outcomes:

  2. Part A

  3. i. Objective response

  4. ii. Disease control at 8 weeks

  5. iii. Time to death

  6. iv. WHO performance status

  7. v. QOL and LCS from the FACT-L questionnaire

  8. Part B

  9. i. Objective response in subjects following treatment with the alternate study treatment

  10. ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment

  11. iii. WHO performance status in subjects following treatment with the alternate study treatment

  12. iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Phase II, Randomized Double-blind, 2-part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-small Cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.

Important dates

Study start
2003
Study completion
2007
First posted
May 5, 2003
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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